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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Tested chemotherapy drugs are as follows:

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.

Warning: Do not use with Carmustine or Thiotepa

The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:

• Ambidextrous with beaded cuff and straight fingers
• Finger-textured,
• Blue colored
• Containing Hyaluronic Acid coating.
• Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
• Tested against chemotherapy drugs and fentanyl citrate.

The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

The provided document is a 510(k) summary for a medical device (nitrile patient examination gloves with hyaluronic acid) and details the performance testing against established standards.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document includes a "Technological Characteristics Comparison Table" (pages 7-9) that serves this purpose. It compares the applicant's device to a predicate device (K200671). The "Acceptance Criteria" column effectively outlines the criteria, and the "Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves..." column shows the reported device performance.

3. Doxorubicin Hydrochloride (2.0mg/), Breakthrough time: >240 min.
4. Etoposide (Toposar) (20.0mg/ml), Breakthrough time: >240 min.
5. Fluorouracil (50.0mg/ml), Breakthrough time:>240 min.
6. Methotrexate (25.0 mg/ml), Breakthrough time: >240 min.
7. Paclitaxel (Taxol) (6.0 mg/ml), Breakthrough time: >240 min.
8. Thiotepa, Breakthrough time: 10.1 min.
9. Vincristine Sulfate (1.0 mg/ml), Breakthrough time:>240 min.
10. Cisplatin (1.0 mg/ml), Breakthrough time:>240 min.
11. Dacarbazine (10 mg/ml), Breakthrough time:>240 min.
12. Mitomycin C (0.5 mg/ml), Breakthrough time:>240 min.
13. Fentanyl Citrate Injection (100 mcg/2ml), Breakthrough time:>240 min. | Similar |

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample sizes for the test sets in the non-clinical tests (e.g., how many gloves were tested for pinholes, how many animals were used for biocompatibility testing). However, it refers to industry standards like ASTM and ISO, which typically define appropriate sample sizes for such tests.

• Provenance: The tests were performed in accordance with international standards (ASTM, ISO). The manufacturing company is Anhui Intco Medical Products Co., Ltd. located in Anhui, China. The testing itself is presented as non-clinical testing to demonstrate performance against these standards. The testing format suggests a retrospective evaluation against pre-defined performance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the document describes performance testing of physical characteristics of gloves against codified standards (ASTM, ISO), not an AI device or a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the pass/fail criteria defined by the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable as the document describes performance testing of physical characteristics against codified standards. There is no subjective adjudication process for the test results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a medical glove, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is a medical glove, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance tests conducted (e.g., tensile strength, pinholes, chemical permeation, biocompatibility) is established by industry standards and test methods (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ASTM D6978-05, ISO 10993 series). These standards define the acceptable range or threshold for a given characteristic to be considered compliant.

8. The sample size for the training set:

This is not applicable. The device is a medical glove, not an AI model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable.

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Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentaryl Citrate, and Select Other Drugs is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

These gloves were tested for use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large, Extra Extra Large. Gloves meet the specification of ASTM D6319- 19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.

The provided documentation describes the non-clinical performance testing of a medical device, specifically Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs (K233598). The study aims to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K223713).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by various ASTM and ISO standards, and the reported performance indicates that the device passed these criteria. The key performance metrics are related to physical dimensions, physical properties (tensile strength, elongation), freedom from holes, residual powder, permeation by chemotherapy drugs and fentanyl citrate, and biocompatibility.

Important Note on Chemotherapy Drugs: The document explicitly states: "Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 1.7 minutes and Thiotepa: 0 minute. Warning: Do not use with Carmustine and Thiotepa." This means that while the glove was tested against these drugs, its performance for them is below the typical acceptable threshold for chemotherapy gloves (which is usually >240 minutes for other drugs), and this is a critical aspect of its labeling and intended use.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not explicitly state the exact sample sizes (number of gloves or individual tests) used for each performance test. It only refers to the standards (e.g., ASTM D6319-19, ASTM D6978-05), which would specify the required sample sizes for testing. For instance, ASTM D6319-19 defines AQL (Acceptable Quality Level) for certain tests (e.g., G-I, AQL 2.5 for water leak test), which implies specific sampling plans.
• Data Provenance: The tests were non-clinical performance studies. The data provenance is linked to the manufacturer, Anhui Intco Medical Products Co., Ltd., China. The tests are described as having been "conducted to verify that the proposed device met all design specifications," implying a prospective testing approach within a laboratory setting, rather than retrospective analysis of existing data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The "ground truth" for glove performance (e.g., tensile strength, breakthrough time, freedom from holes) is established through standardized laboratory testing methods (ASTM, ISO), not through expert consensus or clinical judgment of images or patient data. The results are objective, measurable physical properties and chemical resistance.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation, where human readers might disagree, and a consensus or majority opinion is needed to establish ground truth. For the physical and chemical performance tests of gloves, the results are quantitative and objective, determined by laboratory equipment and standardized procedures.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The device in question is a medical glove, a physical barrier, not a diagnostic tool requiring human interpretation with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The device is a physical product (a glove), not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate. The tests performed are on the physical properties and chemical resistance of the glove itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on:

• Standardized Measurement: Directly measurable physical properties (e.g., length, width, thickness, tensile strength, elongation, residual powder).
• Controlled Chemical Permeation Tests: Breakthrough detection times for specific hazardous chemicals (chemotherapy drugs, fentanyl citrate).
• Biological Testing: In-vivo (animal) and in-vitro tests for biocompatibility (skin irritation, sensitization, acute systemic toxicity) as defined by ISO standards.

Essentially, the "ground truth" is defined by the established and validated protocols of the cited ASTM and ISO standards for testing medical gloves.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (a glove) that undergoes manufacturing processes and performance testing, not an artificial intelligence (AI) or machine learning (ML) algorithm. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this type of device.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Gloves, 80 LZA, and meets all requirements of ASTM standard D-6139 and ASTM D-5250.

The provided text describes the 510(k) submission for Anhui Intco Medical Products Co. Ltd.'s Powder-Free Vinyl Patient Examination Gloves, Yellow Color (K191092). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI-powered medical device through a clinical study.

Therefore, most of the requested information regarding AI device acceptance criteria and study details (such as MRMC studies, standalone algorithm performance, AI training/test set ground truth, and expert qualifications for ground truth establishment) is not applicable to this document.

However, I can extract information related to the performance characteristics that were tested for these medical gloves to demonstrate substantial equivalence.

Here's the information that is applicable based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document compares the subject device (K191092) to a predicate device (K022091) across various physical and biocompatibility characteristics. The "acceptance criteria" here are essentially the performance levels of the predicate device or established standards (like ASTM).

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.

The provided document is a 510(k) Premarket Notification for Powder-Free Clear Vinyl Patient Examination Gloves (K190095). This document is a submission to the FDA (Food and Drug Administration) for a Class I medical device. For such devices, the primary demonstration of meeting acceptance criteria relies on adhering to recognized performance standards and biocompatibility tests.

The document does not describe an AI medical device or a study involving human readers and AI assistance. Therefore, information related to AI-specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) is not applicable and is not present in the document.

Instead, the acceptance criteria and performance data pertain to the physical and biological properties of the examination gloves.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for Powder-Free Clear Vinyl Patient Examination Gloves (K190095)

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• ASTM D5151-06 (Pinhole/Water Leak Test): 125 gloves were tested for the AQL (Acceptable Quality Level) 2.5 sampling.
• Other standards (e.g., ASTM 5250-06 for physical properties, ASTM D6124-06 for residual powder, ISO 10993 series for biocompatibility): Specific sample sizes for these tests are not explicitly stated within the provided text, but industry standards dictate typical sample sizes for such evaluations.
• Data Provenance: The manufacturer is Anhui Intco Medical Products Co., Ltd., located in Anhui Province, China. The testing was conducted by the manufacturer to demonstrate compliance with international standards. The data is retrospective, generated for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. This document pertains to the physical and biological testing of a medical device (examination gloves), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" here is established by the validated methodologies of the ASTM and ISO standards themselves.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a submission for a Class I medical device based on performance standards and biocompatibility, there is no "adjudication" in the sense of expert consensus on image interpretation. The results are quantitative and objective measurements against established standard criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not relevant for the type of device (examination gloves) and the nature of the 510(k) submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The ground truth is based on validated methodologies and acceptance criteria defined by international standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards outline the methods for objectively measuring physical properties (e.g., tensile strength, elongation, dimensions, powder residue, pinholes) and biological responses (e.g., irritation, sensitization, cytotoxicity).

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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